While there has been a consistent stream of RMAT approvals since the designation was created in 2017, with 60 publicly announced to date, the number of approvals in the first few days in 2022 are noteworthy. Specifically, from January 1 to January 18, 2022, four companies publicly announced RMAT designations, as described below.
An RMAT designation is an award from the U.S. FDA that allows for faster, more streamlined approvals of regenerative medicine products within the United States, such as cell and gene therapies, tissue engineering products, and combination products. RMAT designations make innovative products eligible for quicker development and review of a marketing application. [Read more…]
